Costa Mesa-based ICN Biomedicals Inc. said Wednesday that it has received authorization from the U.S. Food and Drug Administration to market a new test for the diagnosis of chlamydia, the obscure but perhaps most common sexually transmitted disease in the nation.
ICN Biomedicals, a majority-owned subsidiary of ICN Pharmaceuticals, said it will begin selling the test kits to physicians in the United States by the end of the year. The test is fast and simple enough to be performed in doctors' offices rather than in diagnostic laboratories, company officials said.
Steven Reid, a health-care analyst with L.H. Friend & Co., an investment banking firm in Century City, said the product could generate $10 million a year in additional revenue and $2 million a year in extra profit for ICN Biomedicals. Reid projects the company will post $70 million in revenues and $5 million in net earnings this year.
The test, which detects antibodies in blood samples that are associated with chlamydia, was developed by Savyon Diagnostics, a small medical technology firm in Israel. ICN said it has the exclusive license to market the test in the United States.
The Centers for Disease Control estimates there are about 4 million chlamydia infections every year in the United States. The disease, which often has no symptoms in early stages, is one of the leading causes of female infertility and ectopic pregnancy.
Despite a growing incidence of chlamydia, there was scant awareness until recently of the importance of the disease, medical experts say.
"Most medical laboratories ignored it because the tests were expensive and rather slow," said James R. Greenwood, director of the Orange County public health laboratory and communicable disease treatment services.
He said more recently far simpler, cheaper and faster tests for the disease have been introduced. Currently, Greenwood said, the county uses a test that in 30 minutes can determine if the disease is present in tissue scraped from the vagina. ICN said its test can confirm the presence of chlamydia in three hours--compared to former culture tests that took up to four days in a clinical laboratory.
Dr. Newton Osborne, an obstetrician/gynecologist and microbiologist at the State University of New York at Syracuse and member of a medical team that did studies of the chlamydia test that ICN plans to market, said he found it to be superior to any other test currently available.
Osborne said that his studies showed that the blood test correctly diagnosed chlamydia in patients where half the time tissue culture tests failed to detect the disease. The reason, he said, is that the disease may be in a part of the body that is not reachable for a tissue sample other than by surgery.
ICN also claims that, unlike other tests for chlamydia, its test can differentiate between early and late stages of the disease. ICN said the test already is on the market in 11 countries.